Augmenting Plasma Separation Component Performance with Software Modification
Location
SU-217
Department
Biology
Abstract
An increase in the demand for medical interventions derived from plasma presents Fresenius Kabi with opportunities to take advantage of a growing market for plasmapheresis medical devices. As part of a continuous improvement initiative to investigate customer questions, the research and development team observed that implementing a modified procedure control software could potentially improve performance of the plasma separation component without making changes to the disposable itself. To determine the effects these software changes would have on the procedure, 4 paired, simultaneous simulated procedures were conducted on two devices of the same plasmapheresis platform, with one device running the experimental software and the other device running existing control software. Data from the device sensors were analyzed, and plasma separation components (PSCs) were disassembled to assess PSC performance. We found that PSCs that were used with the experimental software were more likely to meet specifications compared to PSCs used with the existing control software. No notable changes in relative spectral transmission ratio, pressure readings, cell counts, or plasma collected per cycle were shown. Our results suggest that the implementation of the experimental software could potentially improve PSC performance, with minimal unintentional effects on plasma quality, donor safety, and collection efficiency. While the experimental software may prove promising for future updates, further testing with a larger n is needed to confirm consistent device behavior.
Faculty Sponsor
Elyse Bolterstein
Augmenting Plasma Separation Component Performance with Software Modification
SU-217
An increase in the demand for medical interventions derived from plasma presents Fresenius Kabi with opportunities to take advantage of a growing market for plasmapheresis medical devices. As part of a continuous improvement initiative to investigate customer questions, the research and development team observed that implementing a modified procedure control software could potentially improve performance of the plasma separation component without making changes to the disposable itself. To determine the effects these software changes would have on the procedure, 4 paired, simultaneous simulated procedures were conducted on two devices of the same plasmapheresis platform, with one device running the experimental software and the other device running existing control software. Data from the device sensors were analyzed, and plasma separation components (PSCs) were disassembled to assess PSC performance. We found that PSCs that were used with the experimental software were more likely to meet specifications compared to PSCs used with the existing control software. No notable changes in relative spectral transmission ratio, pressure readings, cell counts, or plasma collected per cycle were shown. Our results suggest that the implementation of the experimental software could potentially improve PSC performance, with minimal unintentional effects on plasma quality, donor safety, and collection efficiency. While the experimental software may prove promising for future updates, further testing with a larger n is needed to confirm consistent device behavior.